Replies to post #495815 on Anavex Life Sciences Corp (AVXL)

[La Flaca]

I'm surprised by your post here: "OLE is meaningless to anyone with experience .." ? Doctors with good reputations in the ALZ field and alot of experience presented this data at AAIC conference. You must be THE leading ALZ expert in the field posing as DOC328. That's the only explanation for your over the top, generalized post here (If you are, what are you doing here? Go figure it out and help them find a way to combat this terrible disease and don't waste your time here). But then you followed up with this ...

"Missling was likely thinking 'maybe if we give them cool names like ABCLEAR1 and ABCLEAR2 (not to be confused with amyloid beta clearance, lol) we can get some more support from retail. I love the COL24A (or should I say ABCLEAR2) GWAS circular data, classic Missling move - test the hypothesis on the same data used to generate it." ??

I think it's likely that you are not credible.

[Guzzi62]

Not according to this lady, Audrey GABELLE • 3rd Professor of Neurology Consultant for big pharma/startups/biotech:

Quote:

When Early Means Better: 4-Year Blarcamesine Results Reinforce the Case for Timely, Targeted Alzheimer’s Treatment
hashtag#AAIC25

▶️ Watch the full presentation on the promising 4-year outcomes and the role of SIGMAR1 in therapeutic response.

New long-term data from the open-label extension of the Phase IIb/III trial of Blarcamesine (ANAVEX®2-73) continues to strengthen the role of precision medicine in Alzheimer’s care.

This once-daily oral therapy, targeting SIGMAR1 activation and restoration of autophagy, has now shown clinically meaningful and sustained benefits over 4 years, especially when treatment begins early.

📊 Key Highlights from the 4-Year Follow-Up:
✅ ADAS-Cog13 difference vs placebo -3.83 points (P = 0.01)
✅ ADCS-ADL difference vs placebo: +4.3 points (P=0.02)
✅ Durable efficacy in the SIGMAR1 wild-type subgroup (~70% of population) ABCLEAR2 population with at week 192 -5.43 (p=0.003) difference for ADASCOg13 and +9.5 (p<0.0001) difference for ADCS-ADL vs placebo
✅ Favorable safety profile with no death or ARIA
✅ Effect supported by biomarkers across the A/T/N framework

🔬 These results highlight the importance of starting therapy early in the disease course and selecting patients based on molecular profiles — a true precision medicine strategy.

👏 Congratulations to the Anavex team and collaborators for delivering long-term data that brings us closer to personalized, effective care for Alzheimer’s disease.

I believe more in Professor GABELLE than you, "Doc".

She is a specialist in the area and so is Prof. Dr. Marwan Sabbagh that was presenting. Those two knows what they are talking about, you are just a bear/short, hence your 1% chance of approval.

https://www.linkedin.com/feed/update/urn:li:activity:7356728984144875521/

The OLE was n=300, where did you get the 84% drop out rate from?

https://clinicaltrials.gov/study/NCT04314934#study-overview

You wrote in another post that the SP might drop to 6 bucks? Well, in the unlikely case they withdraw the application, it might.

You better cover soon, eh?

[Schmiggins]

Doc: "With an 84% dropout rate from baseline visit, OLE is meaningless to anyone with experience."

So the OLE data is based on only 14% of the original patients?

Is it possible the EMA could give approval for just the wild type cohort? It would seem that's the only cohort deserving of the EMA'S time. Could Missling be thinking that that's how it could get approved? It would seem he has to think that.

If not, it would seem his motivation is based on having EU buddies over there who he's counting on giving him a pass. The drug being cheap, a pill, and there's really nothing else as a bit of a fig leaf justification. Could that happen?

Or maybe he figured the EMA head fake could keep interest up until the more powerful Sigmar1 371 drug will show well enough in the Schizo trial in New Jersey to raise money before the EMA failure.

I can see a lot of possibilities but you'll notice almost none of them are based on that trial showing obviously positive results. Other than, as you noted, in that one wild type cohort. I could see the EMA justifying an approval on that one cohort - if they ever do that kind of an approval, or would do such a thing. Any history of that kind of an approval? Anyone?

I've been in Anavex for two years and it's becoming a very strange situation.